This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.
The study included 3 cohorts with one primary endpoint (Objective Response Rate). Enrollment number and completion data is changed by new cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
337
Subjects will receive 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
City of Hope Cancer Center
Duarte, California, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
St. Joseph Hospital
Orange, California, United States
Torrance Health Association
Redondo Beach, California, United States
St Joseph Heritage Healthcare
Santa Rosa, California, United States
Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time frame: Time from first treatment up to data cutoff (approximately Month 66)
Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time frame: Time from first treatment up to data cutoff (approximately Month 66)
Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time frame: Time from first treatment up to data cutoff (approximately Month 66)
Part 1 & 2: Cohort A + B + C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by IRC
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by Investigator
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Progression-free Survival by IRC Assessment
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B +C: Progression-free Survival by Investigator Assessment
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Overall Survival (OS)
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B +C: Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Time frame: Time from first treatment up to end of study (approximately Month 101)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
...and 166 more locations
Part 1 & 2: Cohort A + B + C: Number of Participants With Markedly Abnormal Vital Signs and Physical Examination
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Time from first treatment up to end of study (approximately Month 101)
Part 1 & 2: Cohort A + B + C: Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Time from first treatment up to end of study (approximately Month 101)